FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma

Stomach Neoplasms Clinical Trial

— RusGCG-01  

Official title:

Perioperative Chemotherapy With FOLFIRINOX Regimen or FLOT Regimen for Resectable Gastric or Esophagogastric Junction Adenocarcinoma (Type II-III): Open-label Randomized Phase 2/3 Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04393584
• Other study ID #: 2019-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 29, 2019
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2021
• Source: Blokhin's Russian Cancer Research Center
• Contact: Aleksei Kalinin, Phd
• Phone: +79197681276
• Email: kalininalexey1986[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with resectable adenocarcinoma of the stomach or the esophagogastric junction (II-III type by Siewert) without previous therapy will be treated with one of two chemotherapy combinations before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX). Main objective of the study is median overall survival.

Description:

538 Patients with resectable (cT4cN0 or cT1-4 and cN+, cM0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After randomization patients receive perioperatively 4 cycles FLOT or FOLFIRINOX, followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of FLOT or FOLFIRNOX are applicated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 538
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. ?T4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach without distant metastases (M0)

2. No previous cytostatic chemotherapy or radiation therapy

3. Age 18-70 years (female and male)

4. Eastern Cooperative Oncology Group = 2

5. Surgical resectability

6. Neutrophils> 2.000/µl

7. Platelets > 100.000/µl

8. Normal value of Serum Creatinin

9. Albumin level > 29 ?/?

10. Aspartate transaminase (AST) or alanine transaminase (ALT) less than 3 times the upper limits of normal (ULN)

11. Total Bilirubin less than 1.5 times the ULN

12. Written informed consent.

Exclusion Criteria:

1. Previous cytostatic chemotherapy or radiation therapy

2. Distant metastases or all primarily not resectable stages

3. Cancer relapse

4. Complicated gastric cancer (perforation, bleeding, sub or decompensated stenosis, dysphagia IV)

5. Diarrhea = 2 according to the criteria of Common Terminology Criteria for Adverse Events (CTCAE) version 4.1;

6. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Epirubicin and Docetaxel

7. Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan or Docetaxel

8. Active coronary heart disease, Cardiomyopathy or cardiac insufficiency stage III-IV according to New York Heart Association (NYHA)

9. Severe non-surgical accompanying disease or acute infection (uncontrolled arterial hypertension, diabetes mellitus, stroke less than 6 months old, mental disorders, other tumors and others)

10. Malignant secondary disease, dated back < 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)

11. Peripheral polyneuropathy > Grad II

12. Liver dysfunction (AST)/ALT>3,0xULN, ALT>3xULN, Bilirubin>1,5xULN)

13. Serum Creatinin >1,0xULN

14. Chronic inflammable gastro-intestinal disease

15. Inclusion in another clinical trial

16. Pregnancy or lactation

17. Hepatitis B or C in the active stage

18. Human immunodeficiency virus(HIV) infected

19. Serious concomitant somatic and mental illnesses / deviations or territorial causes that may prevent the patient from participating in the protocol and observing the protocol schedule

20. Foreigners or persons with limited legal status

Related Conditions & MeSH terms

• Adenocarcinoma
• Digestive System Neoplasms
• Docetaxel
• Fluoruracil
• Gastrointestinal Neoplasms
• Irinotecan Hydrochloride
• Neoplasms
• Oxaliplatin
• Stomach Neoplasms

Intervention

Drug:
• Irinotecan
d1 Irinotecan 180mg/m² every two weeks
• 5-FU
d1-2 5-FU 2450 mg/m² every two weeks
• Leucovorin
d1 Leucovorin 200 mg/m² every two weeks
• Oxaliplatin
d1 Oxaliplatin 85 mg/m² every two weeks
• Docetaxel
d1 Docetaxel 50mg/m2 every two weeks

Locations

Country	Name	City	State
Russian Federation	Aleksei Kalinin	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Blokhin's Russian Cancer Research Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median overall survival		2 years
Secondary	Pathologic complete response rate		1 month after surgery
Secondary	Disease free survival		2 years
Secondary	Perioperative Morbidity and Mortality		1 months after surgery
Secondary	R0-Resection rate		1 month after surgery